HEU-EFS Project Featured in JMIR
We’re pleased to share that the HEU-EFS Project has been featured in JMIR, a leading journal in digital health research.
Article Title:
Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union
The article highlights the crucial role of Early Feasibility Studies (EFS) in advancing digital health technologies, including AI-enabled medical devices. It also underlines the importance of a harmonized EU framework to foster innovation while maintaining safety and performance standards.
Key Highlights:
- EFS enable early testing and user feedback, helping innovators refine technologies before full-scale clinical trials.
- EU regulations must evolve to better accommodate the unique needs of digital health technologies.
- The HEU-EFS Project is actively working to improve EFS uptake and streamline pathways for innovators across Europe.
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